Legal Complexities of Global Vaccine Compensation Systems—Reply

Abstract

Ms Mastroianni and Dr Henry question statements in our Viewpoint justifying no-fault compensation schemes for injuries associated with vaccines administered as part of routine clinical practice and in nonemergency situations while using as examples experimental vaccines available during times of public health emergencies. They further suggest that we have not addressed the legal complexities involved in the case of maternal immunization. Our proposal was intended to apply only to recommended, not experimental vaccines, and we regret any confusion the use of examples of vaccines still in development may have caused. Mastroianni and Henry argue this distinction is important because “research-related injuries are rarely covered by any no-fault compensation scheme.” We disagree to the extent the writers suggest that there is not a compensation system to address injuries occurring during clinical trials. As Henry has written elsewhere: “almost every developed country in the world [except the United States] relies on [self-insurance or clinical trial insurance] to meet the needs of injured research subjects,” and clinical trial sponsors in the United States routinely purchase insurance to cover research-related injuries.1 The far larger gap in protecting against serious adverse events globally is for populations immunized after vaccines are recommended and delivered. In the influenza A H1N1 context, for example, recommended vaccines were supported by trials enrolling between 721 and 2768 adults, whereas 61 million persons were vaccinated against the virus after approval.2 Mastroianni and Henry explain the emergency and nonemergency no-fault compensation statutes in the United States. A similar system would not only be possible but welcomed under the complementary global system we advocated. However, other approaches are possible. Some countries may unify their statutory approaches to compensation for routine and emergency vaccinations or give greater authority to certain administrative authorities to declare qualifying vaccines eligible for no-fault compensation during public health emergencies.